Study Comparing Liquid and Tablet Buprenorphine Formulations - 5

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00000302
• Collaborator: (none)
• Enrollment: 0
• Location: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare liquid and tablet buprenorphine formulations.

Condition or Disease	Intervention/Treatment	Phase
Heroin Dependence	Drug: Buprenorphine	Phase 3

Detailed Description

Participants were inducted on either liquid or tablet buprenorphine, in a double-blind, double-dummy manner. They each reached a steady state by the second week, and were scheduled to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.

Study Design

• Study Type: Interventional
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations

Outcome Measures

Primary Outcome Measures

1. Drug use []

2. Retention []

3. Drug craving []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Friends Research Institute	Los Angeles	California	United States	90025

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Walter Ling, M.D., Friends Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00000302
• Other Study ID Numbers: NIDA-09260-5; P50-09260-5
• First Posted: Sep 21, 1999
• Last Update Posted: Nov 7, 2005
• Last Verified: Dec 1, 2002

• Additional relevant MeSH terms: Heroin Dependence; Buprenorphine

Study Results

No Results Posted as of Nov 7, 2005